Protein Kinase A in Prostate Cancer Tissue. | NCT05460312

Studies
Protein Kinase A in Prostate Cancer Tissue.

NCT05460312

Sponsor

Ziv Hospital

Status

Unknown status

Last Update Posted

Jan 26, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Prostate Neoplasm
Inflammation
Benign Hyperplasia of Prostate

Interventions

prostate biopsy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Estimated

Primary Completion Date

Mar 2024Estimated

Completion Date

May 2024Estimated

First Submitted Date

Jul 12, 2022

First Submission Date that Met QC Criteria

Jul 14, 2022

First Posted Date

Jul 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2023

Last Update Posted Date

Jan 26, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ran Katz, Dr. Ran Katz, Head, department of Urology, ziv medical center, Ziv HospitalPrincipal Investigator

Lead Sponsor

Ziv HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prostate cancer is the most common malignancy in men. documented risk factors of prostate cancer are age, ethnicity, various genomic mutations and family history of prostate cancer. The cellular mechanisms of malignant transformation are numerous and not completely understood. A possible mechanism is induction of an inflammation resulting in cellular atypia and pre-malignant changes in the affected tissue by inducing a pro-inflammatory response or changes in extra cellular matrix. Protein Kinase A (PKA) is a key stone enzyme in various intra-cellular processes. Various infections' inflammations and malignancies were proved to impact PKA activity. The research hypothesis is that prostate cancer tissue will show a unique profile of PKA activity, regulation and intracellular distribution.

Detailed Description

The study will be conducted among men referred to prostate biopsy due to clinical suspicion of malignancy. 100 consecutive patients will undergo prostate biopsies. Biopsies will be taken from both lobes of the prostate (standard protocol) and additional biopsies will be taken according to MRI findings (Fusion biopsies) if relevant. One additional biopsy will be taken from each lobe of the prostate and immediately freezed in -80 Celsius degrees. Routine biopsies will be fixed in formaldehyde and embedded in paraffin and will undergo routine pathological analysis and staining.

Following pathological analysis, paraffin slides will be undergo immunohistochemically staining for PKA, comparing cancerous tissue to normal surrounding tissue. the fresh frozen tissue will undergo western blot analysis for quantitative expression of PKA and its sub units.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
prostate biopsy	Diagnostic Test	trans rectal ultrasound guided biopsies of prostate . Biopsy smaples will be referred to staining and western blot analysis.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The distribution of PKA in prostate cancer versus benign tissue	Immunohistochemical staining of paraffin sections of prostatebiopsies for PKA, western blot analysisi of tissue.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men
Clinical suspicion of prostate cancer
Referred for biopsy
Able to sign informed consent.

Exclusion Criteria:

Previous prostate irradiation
Chronic prostatitis
Previous prostate surgery
Recent urinary tract infection (3 months prior to biopsy).
Indwelling urinary catheter

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Men referred to prostate biopsies.

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

A cohort of 100 consecutive men referred to prostate biopsy due to clinical suspicion of prosatet cancer.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D007249	Inflammation
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

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Browse Branches

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